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Purpose <p>[<sup>99m</sup>Tc]Tc-sestamibi SPECT/CT (MIBI SPECT/CT) is a promising tool to differentiate benign and malignant renal tumours. We tested feasibility of recruitment to a prospective, multi-centre diagnostic test evaluation study of MIBI SPECT/CT for T1 renal tumours.</p> Methods <p>Consecutive adult patients with a newly-diagnosed clinical T1 (cT1) renal mass (2–7&#xa0;cm) presenting to participating sites December 2022 - February 2024 were recruited and underwent MIBI SPECT/CT prior to histopathological diagnosis. Patients who accepted and declined participation and clinicians involved in study activities were invited to a semi-structured interview. The primary endpoint was feasibility of multi-centre recruitment. Secondary endpoints included qualitative assessment of barriers and facilitators to participation, estimates of MIBI SPECT/CT accuracy to detect cancer in order to power a definitive study, inter-rater agreement and identifying training needs for scan acquisition and interpretation.</p> Results <p>Of 109 approached patients, 50 enrolled and underwent the study scan (45.8%, 95% CI 36.2–55.7%) across 6 sites. MIBI SPECT/CT scans were acquired and reported without the need for significant additional training. All scans were of adequate quality for interpretation. Sensitivity and specificity of MIBI SPECT/CT to detect cancer were 97.0% (95% CI 84.2–99.9%) and 53.8% (25.1–80.8%), respectively.</p> Conclusion <p>MULTI-MIBI has demonstrated feasibility of recruitment to a diagnostic evaluation study for T1 renal masses. Preliminary estimates of diagnostic accuracy suggest that MIBI SPECT/CT could reduce the number of patients with benign tumours undergoing surgery without missing a significant number of patients with malignant disease, however these results are limited by the small sample size in this feasibility study and a larger definitive study is needed prior to adoption in practice.</p>

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[99mTc]Tc-sestamibi SPECT/CT for the diagnosis of kidney tumours: a multi-centre feasibility study (MULTI-MIBI Study)

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年9月23日

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  • Hannah Warren,
  • Thomas Wagner,
  • Soha El-Sheikh,
  • Nick Campain,
  • Tze M. Wah,
  • Tim S. O’Brien,
  • Iosif A. Mendichovszky,
  • Sabina Dizdarevic,
  • Charlie Stewart,
  • Helen Ng,
  • James Blackmur,
  • Patrick Rogers,
  • Andrew Scarsbrook,
  • Dhruba Dasgupta,
  • Fahim Ul-Hassan,
  • Nitasha Singh,
  • Ammar Alanbuki,
  • Maryam Jessop,
  • Linda Park,
  • Kelly Leonard,
  • Alex Wood,
  • Ben Challacombe,
  • Grant D. Stewart,
  • Ravi Barod,
  • Prasad Patki,
  • Faiz Mumtaz,
  • Axel Bex,
  • Veeru Kasivisvanathan,
  • William Wildgoose,
  • Sigrun Clark,
  • Cecilia Vindrola-Padros,
  • Elena Pizzo,
  • Hakim-Moulay Dehbi,
  • Mark Emberton,
  • Maxine GB Tran

摘要

Purpose

[99mTc]Tc-sestamibi SPECT/CT (MIBI SPECT/CT) is a promising tool to differentiate benign and malignant renal tumours. We tested feasibility of recruitment to a prospective, multi-centre diagnostic test evaluation study of MIBI SPECT/CT for T1 renal tumours.

Methods

Consecutive adult patients with a newly-diagnosed clinical T1 (cT1) renal mass (2–7 cm) presenting to participating sites December 2022 - February 2024 were recruited and underwent MIBI SPECT/CT prior to histopathological diagnosis. Patients who accepted and declined participation and clinicians involved in study activities were invited to a semi-structured interview. The primary endpoint was feasibility of multi-centre recruitment. Secondary endpoints included qualitative assessment of barriers and facilitators to participation, estimates of MIBI SPECT/CT accuracy to detect cancer in order to power a definitive study, inter-rater agreement and identifying training needs for scan acquisition and interpretation.

Results

Of 109 approached patients, 50 enrolled and underwent the study scan (45.8%, 95% CI 36.2–55.7%) across 6 sites. MIBI SPECT/CT scans were acquired and reported without the need for significant additional training. All scans were of adequate quality for interpretation. Sensitivity and specificity of MIBI SPECT/CT to detect cancer were 97.0% (95% CI 84.2–99.9%) and 53.8% (25.1–80.8%), respectively.

Conclusion

MULTI-MIBI has demonstrated feasibility of recruitment to a diagnostic evaluation study for T1 renal masses. Preliminary estimates of diagnostic accuracy suggest that MIBI SPECT/CT could reduce the number of patients with benign tumours undergoing surgery without missing a significant number of patients with malignant disease, however these results are limited by the small sample size in this feasibility study and a larger definitive study is needed prior to adoption in practice.